More than a dozen years ago, a medical device hit the market with a tantalizing promise: It could freeze away stubborn pockets of fat quickly, painlessly and without surgery. A beauty treatment promised to zap fat. For some, it brought disfigurement:
More than a dozen years ago, a medical device hit the market with a tantalizing promise: It could freeze away stubborn pockets of fat quickly, painlessly and without surgery.
Allergan Aesthetics, a unit of the pharmaceutical giant AbbVie that now owns CoolSculpting, says this is rare, occurring in 0.033% of treatments, or about 1 in 3,000.The company behind CoolSculpting has retained consultants who have written about low risks of PAH in medical journals and online channels.
As CoolSculpting’s popularity rapidly grew, problems were quietly developing for some patients. In 2011, soon after the initial FDA clearance, Zeltiq learned of a person whose treated fat had solidified into a noticeable mass, according to an internal company document obtained by the Times. More discrepancies in data would follow, in part because the company and its consultants used the number of treatments to calculate the risk of PAH, while physicians observing the side effect usually used the number of patients.
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